TGA makes final decision to reduce paracetamol pack sizes

The Therapeutic Goods Administration (TGA) has today published a final decision to reduce the maximum size of packs for various paracetamol products.

Each year in Australia around 225 people are hospitalised with liver injury and 50 Australians die from paracetamol overdose, with rates of intentional overdose highest among adolescents and young adults. This decision aims to reduce the harm from intentional overdose.

From 1 February 2025, new restrictions on paracetamol will:

• reduce the maximum size of packs available for general sale (e.g. supermarkets and convenience stores) from 20 to 16 tablets or capsules
• reduce the maximum size of packs available in pharmacies without the supervision of a pharmacist (i.e. ‘Pharmacy Only’ packs) from 100 to 50 tablets or capsules
• make other pack sizes of up to 100 tablets or capsules available only under the supervision of a pharmacist (‘Pharmacist Only’ medicines).

Paracetamol tablets and capsules for both general and Pharmacy Only sale will also be required to be in blister packaging. The maximum size of Pharmacy Only packs of individually wrapped powders or sachets of granules containing paracetamol will also be reduced in line with tablet and capsule packs.

Access to liquid, modified-release and Schedule 4 (Prescription Only) paracetamol is not affected by this decision.

The final decision to change the scheduling of paracetamol in the Poisons Standard has been made following consultation in February-March 2023 on an interim decision that proposed changes to maximum paracetamol pack sizes and packaging. The final decision carefully considered the feedback and balances the need for some restrictions to pack sizes while ensuring continued access to larger packs for those people who need regular pain relief.

The decision takes into account:

• an independent expert report commissioned by the TGA that examined the incidence of serious injury and death from intentional paracetamol overdose.
• advice received from the Advisory Committee on Medicines Scheduling (ACMS).
• submissions from two rounds of consultation from individuals, and organisations representing consumers, healthcare practitioners and industry.

To further minimise the harm from paracetamol overdose, the TGA is encouraging retailers such as supermarkets to restrict sales to a single pack at a time. The TGA is also encouraging consumers not to stockpile paracetamol in their home and to appropriately store paracetamol and other medicines. To allow manufacturers and retail outlets sufficient time to adjust, the decision takes effect from 1 February 2025.

More information is available in the paracetamol questions and answers.

Contact for members of the media:
Email: news@health.gov.au
Phone: 02 6289 7400